Skip to main content
OpenTrials
Completed

NCT Number: NCT03519815

Clinical Study to Evaluate the Efficacy of Ectoin® Containing Eye Spray for Treatment of Dry Eye Disease

Subjective and objective evaluation of the efficacy and tolerability of preservative-free "Ectoin® Eye Spray - Colloidal" and comparison of the efficacy and tolerability between "Ectoin® Eye Spray - Colloidal" and Tears Again® in patients with mild-moderate dry eye disease

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Optometry, FHNW

Olten, Canton of Solothurn, 4600, Switzerland

About this study

"Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neuro- sensory abnormalities play etiological roles." (DEWS II Report, 2017).

For the treatment and prevention of dry eye disease (DED) there are a number of treatment modalities available, depending on the severity and classification (aqueous deficient / evaporative) of the disease. The liposomal eye spray Tears Again® (TA, Optima Medical Swiss AG - medical device with CE marking) represents an option to treat mild to moderate evaporative DED. A novel preservative-free eye spray, Ectoin® Eye Spray - Colloidal (EES09; bitop AG -medical device with CE marking), was developed, in which colloids (colloidal lecithin emulsion) serve as a carrier for Ectoin. Ectoin is known as a natural cell-protective and inflammatory-inhibiting molecule. The principle mode of action of Ectoin is based on the physical interaction of this compatible solute with water and the resulting effects of the Ectoin-Hydro-Complex on the tissue treated.

The aim of this study is to subjectively and objectively evaluate the efficacy and tolerability of preservative-free "Ectoin® Eye Spray - Colloidal" and to compare the efficacy and tolerability between "Ectoin® Eye Spray - Colloidal" and Tears Again® in patients with mild-moderate dry eye disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minimum age 18 years
  • OSDI Score of at least 18
  • NIBUT smaller or equal to 10s in at least one eye

Exclusion criteria

  • Post-operative trauma or injury
  • Ocular disease with exception of DED
  • Hypersensitivity to any of the ingredients in the products used for this study
  • Contact lens wear 24h before or on the day of study visits
  • Use of eye drops / other eye sprays on the day of visit 1 or during the duration of the study period

Treatment and study plan

Ectoin® Eye Spray - Colloidal

Device

eye spray to be applied to the closed eye lid

Liposomal eye spray Tears Again®

Device

eye spray to be applied to the closed eye lid

Primary outcomes

  1. Difference in subjective variables 10min after application and after the treatment period with the eye sprays, in comparison to baseline measurements (visit 1).

    Time frame: 10min

    ocular surface disease index (OSDI) questionnaire, VAS questionnaire for evaluation of dry eye symptoms and tolerability of the eye spray.

  2. Difference in tear film quality

    Time frame: 10min

    non-invasive tear film break up time (NIBUT)

  3. Difference in tear film osmolarity

    Time frame: 10min

    osmolarity measurement

  4. Difference in conjunctival bulbar redness

    Time frame: 10min

    grading of conjunctival bulbar redness

Secondary outcomes

  1. Difference in subjective variables after the treatment period between the two eye sprays.

    Time frame: 10 +/- 3 days

    ocular surface disease index (OSDI) questionnaire, VAS questionnaire for evaluation of dry eye symptoms and tolerability of the eye spray.

  2. Difference in tear film quality

    Time frame: 10 +/- 3 days

    non-invasive tear film break up time (NIBUT)

  3. Difference in tear film osmolarity

    Time frame: 10 +/- 3 days

    osmolarity measurement

  4. Difference in conjunctival bulbar redness

    Time frame: 10 +/- 3 days

    grading of conjunctival bulbar redness

Sponsors and collaborators

Lead sponsor

University of Applied Sciences and Arts Northwestern Switzerland

Other

Registry information

Official study title

Prospective Randomized Study to Evaluate the Efficacy and Tolerability of Ectoin® Containing Eye Spray (EES09) and Comparison to the Liposomal Eye Spray Tears Again® (TA) in the Treatment of Dry Eye Disease

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 9, 2018
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.